Operational Manager
Há 23 horas
This role serves as the technical operations single point of contact for Apheresis and Treatment Centres located within designated regions.
- Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
- Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for assigned region.
- Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within required timelines.
- Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
- Perform technical site assessments and train collection center staff on collection requirements and attend site audits as required. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
- Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
- Manage rollout of process changes to assigned sites. Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.
- Collect and enter data into electronic data management systems. Represent the department on cross-functional project teams, as requested.
- Comply with applicable SOPs and regulations.
- Breadth of experience in regulated environments, understanding of HTA.
- Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
- Experience managing contracts with external apheresis providers.
- Prior customer-facing role in pharmaceutical/biotech industry.
- Ability to rapidly solve problems and deal with organizational complexity.
- High attention to detail skills.
- Excellent interpersonal and presentation skills to communicate effectively across all levels within the organization and multiple cultures.
- Undergraduate degree in related science or nursing.
- Advanced degree in related science or nursing.
- Fluency in English and Portuguese.
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